Disposable human waste management devices with improved adhesive flange to facilitate adhesion in oily conditions

ABSTRACT

The present invention relates to a disposable human waste management devices such as fecal and urine management devices (10) which are provided with adhesives for attachment of the device to the skin. In particular the present invention relates to adhesives (20) which provide secure attachment and are pleasing to the skin upon application, yet cause no discomfort upon removal. In particular the present invention relates to adhesives which provide secure attachment to oily and greasy skins. Preferably the adhesive also provides secure attachment under moist and wet skin conditions and which maintains adhesive peel strength even under exposure to excess water.

PRIOR APPLICATION

This application is a continuation of PCT Application No. PCT/US00/02768filed on Feb. 2, 2000 and published in English.

FIELD OF THE INVENTION

The present invention relates to a disposable human waste managementdevices such as urine management devices and faecal management devicesfor babies, children or adults to be attached directly to the skinbetween the buttocks of the wearer. The device utilises an improvedadhesive so as to facilitate easy application and removal of the devicefrom the wearer, whilst ensuring maintenance of the device in thedesired position. In particular the adhesives provide attachment ongreasy and oily skin.

BACKGROUND OF THE INVENTION

Urine and faecal management devices are known articles of manufacturethat are designed to be worn principally by incontinence sufferers andin particular by bedridden patients. Such devices are attached to thenatural anal region or artificial anus of the wearer and or uro genitalarea and are intended to receive entrap and immediately contain urine,faecal material and other bodily discharges.

Such devices as they are mostly known today are designed to be worn bybedridden patients. As such the devices are constituted of a relativelylong and narrow tube, at one extremity of which there is an aperture anda skin attachment device upon which an adhesive can be applied.

Examples of these bags are disclosed for example in U.S. Pat. No.3,577,989, which details a disposable elimination-trapping bag forincontinence sufferers including a container member having an open-topportion, and a flange secured to the container member around theopen-top portion. The flange may include a layer of adhesive on itssurface as a means of attachment of the bag to the wearer oralternatively discloses the use of elastic straps to attach the bag tothe wearer. U.S. Pat. No. 4,784,656 also describes a receptacle forcollecting faecal matter from incontinence sufferers. The faecalcollector comprises a gasket, conduit means or a cylinder and areceptacle; the receptacle and conduit means are each formed from twosheets of odour barrier thermoplastic film that are heat sealed alongtheir side edges, respectively and the side surface of the gasket iscoated with a layer of adhesive; GB 2 152 387, teaches a faecalcollector for incontinence sufferers comprising a collection bag and aring, which is provided with an adhesive. The faecal collector comprisesa pair of panels of thermoplastic sheet material joined at their marginsto define an elongate bag having an opening at one end. GB 1 078 588describes a urine collector comprising a liquid proof bag of tube likeconfiguration having an opening surrounded by an attachment means in theform of an adhesive bearing material.

Other types of faecal management bags having a flatter shape are knownfrom EP 245 064. EP 245 064 discloses bags having a front and a rearwall, the front wall containing the aperture and attachment means to thebody. The attachment means is a skin compatible water resistant materialsuch as a hydrocolloid and a water insoluble viscose elastic binder.

Due to their typical elongated shape and dimensions, such devicesparticularly when worn by active wearers, such as infants or nonbedridden incontinent adults, can readily twist around the thighs of thewearers and/or can cause the formation of folds and kinks in the devicesthemselves. Under such circumstances the pressure and stress exertedupon the bag will naturally increase due to the movement of the wearerand the pressure of the wearer's body upon the bag. Consequently, thelikelihood that the urine or faecal material once excreted and containedwithin the bag will be caused to exert pressure upon the attachmentmeans of the device will increase. As a result not only will the storagecapacity of the device be detrimentally affected but also moreimportantly it may result in unintentional detachment of the device fromthe wearer during use. Such an occurrence is unacceptable causingdistressing consequences for both the wearer and the carer.

Hence, it is critical that the urine and/or faecal management devicesare designed such that they are securely attached to the skin of thewearer and do not become unintentionally unattached during allcircumstances of use.

In order to provide the desired level of adhesion of the device to thewearer, the prior art typically discloses the utilisation of certainadhesives having very high cohesive strengths such as rubber basedadhesives and acrylics. These adhesives are then applied as thick layersover the entire surface of the flange of the device to maximise theadhesive force by which the device is secured to the skin of the wearer.Indeed it is apparent that these devices, and in particular theadhesives, have been designed for use on faecal management devicesutilised by bedridden patients particularly those having an artificialanus whereby maximum adhesion takes priority over any other criteriasuch as patient comfort.

However, the adhesive must have a skin compatible composition and not beharsh or aggressive towards the skin or cause skin irritation orinflammation. Also it is preferred if the adhesive is compliant with theskin of the wearer such that maximum skin surface contact between theadhesive and the skin is achieved. Moreover, it is also desirable toprovide an adhesive such that the disposal human waste management devicecan be readily removed from the wearer, without the wearer experiencingany unacceptable pain level. This is particularly important undercircumstances, where the device is misplaced, and removal andreapplication of the device once or even a number of times is requiredand or to ensure the application of such devices on sensitive skin andwearer groups such as infants. However, on the other hand the desiredlevel of adhesion, albeit painless should of course also be maintainedduring such multiple applications of the device.

The problem of achieving the desired adhesion level is furtherexacerbated under wet skin conditions. Typically, prior to the placementof the disposable human waste management device, the skin is cleaned andis usually as a result moist. The currently available adhesives, such asthose containing hydrocolloid particles, however often do notimmediately strongly adhere to the skin and may need to be held in placeuntil sufficient minimum adhesion occurs. Moreover, the overall adhesiveability of such adhesives tends to be significantly reduced on wet skinsurfaces per se, so that the device will typically not remain attachedto the skin during wear if any pressure is exerted onto the device, forexample by the movement of the wearer or during the defaecation process.Alternatively adhesives which are able to absorb water and thusimmediately adhere to moist skin, tend to absorb water very rapidly andnot in a controlled manner such that extended adhesion time is notprovided.

Another problem which is associated with adhesives which do not maintaintheir adhesive strength after exposure to liquids is that not only willthe adhesive no longer adhere satisfactorily to skin, it will also nolonger adhere to the flange.

Moist and wet skin however is not just a problem which is prevalent atthe device application stage, as a significant amount of moisture isalso generated during the use of the device from the wearer byperspiration and from the material contained within the disposable humanwaste device. In addition particularly for the case of urine managementdevices, small amounts of liquid may be deposited or migrate on to theflange surface without entering the bag cavity. The resulting humidenvironment naturally further increases when the device is utilised incombination with a diaper. Under such circumstances currently availableadhesives typically cannot absorb this moisture and again the adhesivestrength is reduced to such an extent that the device will often becomedetached under exertion of pressure during wear. It is hence veryimportant to provide an adhesive which provides both initial adhesionand maintenance of its adhesive strength on wet skin. Moreover, it isalso another important factor for the product performance that theadhesive is also stable to exposure to excess quantities of liquid suchas water and in particular urine, so that it will also not loose itsadhesive strength under such circumstances.

Another problem which is particularly prevalent for urine and faecalmanagement devices is the ability for the adhesive to adhere on greasyor oily skin surfaces. The levels and types grease or sebum naturallypresent on the skin vary from person to person. In addition the wearersof such products typically utilise creams such as moisturising creams orrash creams or other pharmaceutical creams on the area of skin typicallyin contact with the adhesive of the device. Thus it is also desirablethat the adhesive exhibits an ability to adhere to greasy skin.

None of the prior art in the field of faecal management bags howevereven recognises or addresses the problem of providing these devices withan adhesive which meets these criteria, in particular adhesives whichadhere to wet skin and are stable and maintain their adhesiveness evenwhen exposed to excessive amounts of liquid or adhesives which adhere tooily and greasy skin.

The prior art in the general field of adhesives for attachment to theskin is in contrast more developed in the field of articles such asband-aids, plasters and bandages. These articles are however typicallyapplied in an emergency situation, where for example, a cut into theskin of the wearer has occurred and absorption of the body liquidsemanating from a wound is desired. In this context performance aspectsof the article such as easy application and use of the product,comfortable wear as well as painless removal, and discreteness are againsubordinate, to other criteria in this case such as sterility, healingsupport, and mechanical protection of the wound. Such products typicallyhave poor wet skin adhesion.

Adhesion to wet skin is addressed for example in WO 98/03208 whichdiscloses medical pressure sensitive adhesives which can adhere to dryor wet skin and which comprise a mixture of hydrophilic (meth)acrylatecopolymer containing tertiaryamino groups, a hydrophilic (meth)acrylatecopolymer containing carboxyl groups, carboxylic acids and acrosslinking system. However this document does not discuss adhesionafter exposure to excess liquid. Similarly, WO 97/24149 discloses apolar lipophilic pressure sensitive adhesive comprising a hydrophilicpolymer matrix, a plasticizing solution and a surfactant that providesgood adhesion to a variety of skin types.

Another field wherein the use of such adhesives has been disclosed is inabsorbent such as for example sanitary napkins, as described in forexample US statutory invention registration H1602 or WO 96/33683 and WO95/16424. The latter discloses sanitary articles having a topicaladhesive which is applied on the wearer facing side of a sanitary napkinalong the entire periphery. WO 96/13238 discloses a topical adhesivewhich is described in terms of frequency dependency. EP-638 303discloses the use of a topical adhesive on side cuffs of sanitarynapkins in order to keep the cuffs in an upright position. Swisspublication CH-643730 discloses the use of a very long sanitary napkinhaving chamfered outer edges with a topical adhesive at the four cornersof the outer edges in order to provide a topical adhesive area welloutside the region of pubic hair growth.

However all of these disclosures typically disclose a product which isdesigned to be utilised in combination with an undergarment and hencethe degree of adhesion actually provided is very low and is not designedto withstand any excessive pressure. Moreover the adhesive is onlydiscussed in general terms or concentrates on the area of application ofthe adhesive to the article. The nature of adhesive per se other thanthe basic physical requirements such as pressure sensitivity are notdiscussed in particular with reference to the chemical composition orthe adhesive criteria.

Hence there still exists a need to provide disposable human wastemanagement devices having an adhesive for the secure attachment andpainless removal of the device from the skin in-between the buttocks ofthe wearer so as to be suitable for use of sensitive skin of an infantand it is thus an object of the present invention to provide such adevice.

It is another objective of the present invention to provide an adhesivethat exhibits an ability to adhere to skin upon reapplication,particularly multiple reapplication for example when the device ismisplaced, whilst still allowing painless removal.

It is another object of the present invention to provide an adhesivethat will adhere to oily and greasy skin, preferably over the entireperiod of wear.

It is yet a further objective of the present invention that the adhesivewill adhere to moist or wet skin, independent of whether this is directapplication of the device onto wet skin, or moisture which is generatedon the skin surface during the wearing period of the device. Inparticular it is an objective of the present invention to provide anadhesive which is liquid stable particularly to water and urine, suchthat the adhesion properties will not be significantly affected in thepresence thereof over the period of wear of the device.

It is another object of the present invention to provide an adhesivewhich upon removal from the skin of the wearer leaves no residues. It isyet another object of the present invention to provide an adhesive whichdoes not cause a cold or otherwise unacceptable temperature sensationupon application to the wearer.

An additional object of the present invention to provide an adhesivewhich in combination with the flange material provides flexibility,stretchability and contractability so that it is able to adapt to thecontours of the body during all bodily movements and hence becomfortable for the wearer of the device, whilst still having sufficientadhesive capacity to ensure secure attachment during use.

It has now been surprisingly found that the above drawbacks will besubstantially alleviated by providing the flange of the disposal humanwaste management device with an adhesive as defined hereinafter. Theadhesive provides secure attachment including to moist and oilysurfaces, is pleasing to the skin upon application, and yet causes nodiscomfort upon removal and maintains its adhesive strength over theperiod of wear under varying conditions.

In another aspect of the present invention, the disposal human wastemanagement device with its specific adhesive as defined herein can beadvantageously used in combination with a reusable underwear garment orpreferably with a disposable diaper.

BRIEF DESCRIPTION OF THE DRAWINGS

It is believed that the invention will be better understood from theforegoing description in conjunction with the accompanying drawings inwhich:

FIG. 1 is a perspective view of a disposable faecal management device inaccordance with the present invention.

FIG. 2 shows a perspective view of the disposable faecal managementdevice in conjunction with a disposable diaper; and

FIG. 3 is a partially cut-away perspective view of a disposable diaperembodying a faecal management device of the present invention.

FIG. 4 is a plan view of a disposable urine management device of thepresent invention.

SUMMARY OF THE INVENTION

Any disposable human waste management device known in the art can beprovided with the adhesive according to the present invention. Typicallyurine and faecal management devices comprise a bag (11) having anaperture (21) and a flange (12) surrounding the aperture for adhesiveattachment to the uro-genital area and or the perianal area of a weareras visible from FIG. 1. According to the present invention the adhesiveis provided so as to have an initial dry skin peel strength (P_(DI)) andan initial greasy skin peel strength (P_(GI)) measured according to thetest method herein, which has a ratio of P_(DI) to P_(GI) of from 1:1 to1:0.2, preferably from 1:1 to 1:0.3.

According to the present invention the adhesive is also preferablyprovided so as to have an initial peel strength (P_(DI)) under normalambient conditions and a final peel strength (P_(WF)) after exposure towater according to the test method described herein, whereby the ratioof P_(DI) to P_(WF) is from 2:1 to 1:4 preferably from 2:1.25 to 2:4 andhas a water absorption capacity as defined in the test herein of atleast 3% by weight of said adhesive.

The adhesive allows attachment of disposable human waste managementdevices to the skin of the wearer, the adhesive being provided as alayer having a certain thickness or calliper C measured in millimeters(mm), typically on at least part of the wearer facing surface of theflange.

Detailed analysis of the sequence of common situations occurring fromthe application of a faecal management device to the time of removal ofsuch a device has shown that specific adhesive characteristics need tobe preferably satisfied in order to achieve the desired performanceobjectives, in particular to secure initial attachment, secureattachment during use and painless removal after wear. Thecharacteristics which have been considered in this context are theelastic modulus describing the elastic behaviour of the material and theviscous modulus which describes the viscous behaviour of the adhesivematerial.

The viscous behaviour of the adhesive can be interpreted to represent anindication of the ability of the adhesive to quickly attach and securelyadhere to a particular surface. The elastic behaviour can be interpretedas an indication of the “hardness” behaviour of the adhesive. Its valueis also important for good initial attachment. Their combination isbelieved to be an indicator of the required force upon removal. Therelation between elastic and viscous modulus is considered to be anindication on which fraction of the removal energy will be dissipatedwithin the adhesive and which fraction is available to trigger theactual removal.

In order to provide topical adhesives for secure initial and prolongedattachment and easy/painless removal the relation between the elasticmodulus and the viscous modulus as well as their dynamic behaviour isalso of importance.

The adhesive has an elastic modulus at a temperature of 37° C. (100°Fahrenheit) abbreviated G′₃₇, a viscous modulus at a temperature of 37°C. (100° Fahrenheit) of G″₃₇, and a viscous modulus at a temperature of25° C. (77° Fahrenheit) of G″₂₅.

The adhesive according to the present invention preferably satisfies thefollowing conditions;

G′₃₇ (1 rad/sec) is in the range 500 Pa to 20000 Pa,

preferably 700 Pa to 15000 Pa, most

preferably 1000 Pa to 10000 Pa.

G″₃₇ (1 rad/sec) is in the range 100 Pa to 15000 Pa,

preferably 100 Pa to 10000 Pa, most

preferably 300 Pa to 5000 Pa.

and the ratio of G′₃₇ (1 rad/sec)/G″₃₇ (1 rad/sec) is in the range of 1to 30.

Provided the above theological conditions are satisfied the adhesiveswill also satisfy conditions such as sufficient cohesiveness (to preventresidue of adhesive on the skin) which are important for commercial useof such adhesives and apparent to those skilled in the art. Adhesivecompositions which satisfy the above criteria can be used as adhesivesfor the flange provided they also satisfy the common requirements ofbeing safe for use on human or animal skin during use and generallyafter disposal of the device.

Often the criteria of hygienic appearance such that adhesivecompositions which are transparent or white upon application arepreferred.

It has been determined that the relation between the thickness orcalliper C, measured in millimeters (mm), of the layer in which theadhesive is provided, typically onto at least a portion of the wearerfacing surface of the flange, and the viscous modulus G″₂₅ at about 100rad/sec of the adhesive, is relevant to the scope of providing an easyand painless removal from the wearer's skin of such a adhesive appliedon at least part of the wearer facing surface of a faecal managementdevice for attachment of said device to the skin of a wearer.

The adhesive of the present invention is thus preferably provided as alayer having a thickness C such that the viscous modulus G″₂₅ (100rad/sec) and the thickness C preferably satisfy the following empiricalequation:

G″ ₂₅≦[(7.00+C)×3000]Pa

and preferably also the following empirical equation:

G″ ₂₅≦[(5.50+C)×1700]Pa

DETAILED DESCRIPTION OF THE INVENTION

According to the present invention the adhesive can be utilised ondisposable human waste management devices such as a faecal or urinemanagement devices (10) which are applied to the perianal area of awearer as visible from FIG. 1. The word “skin” according to the presentinvention does not only relate to the specific derma of the user butincludes the mucous tissue as well as the hair which is typically foundin the genital region.

The skin of the wearer to which devices are typically applied will varyconsiderably from person to person. In particular the type and amount ofgrease or sebum produced can vary considerably from person to person.Moreover, the wearers of such devices typically will apply creams to thearea of skin which will contact the adhesives. These creams may be of apurely cosmetic nature i.e. moisturing creams or may be creams used totreat certain skin conditions by which the wearer may be afflictedranging from mild skin irritation, and diaper rash to haemorrhoids andother more serious skin afflictions. In the latter case the use of suchcreams plays an essential role in the treatment of wearer's conditionand cannot be relinquished. It is thus important to provide an adhesivewhich adheres to greasy skin. Accordingly the present invention providesan adhesive having a dry initial peel strength (P_(DI)) and a greasyinitial peel strength (P_(GI)) as determined by the test methoddescribed herein, where the ratio P_(DI) to P_(GI) is from 1:1 to1.0:0.2, preferably from 1:1 to 1:0.3. Typically for utilisation fordisposable human waste management devices the dry initial peel strengthis (P_(DI)) is from 0.1N/cm to 7.0N/cm, preferably from 0.1N/cm to5.0N/cm, more preferably from 0.5N/cm to 3N/cm. The value of the greaseinitial peel strength is preferably the same as for the dry initial peelstrength. However typically a lower level is achieved and is acceptableat levels from 0.1N/cm to 5N/cm, preferably from 0.1N/cm to 3N/cm, morepreferably from 0.1N/cm to 2N/cm. It is also preferable of the adhesionto greasy skin is maintained over a period of wear time.

Due to the nature and environment in which such disposable human wastemanagement devices such as urine and faecal management devices areutilised it is also preferably a feature that the adhesive has a waterabsorption capacity as defined in the test herein of at least 3% byweight of said adhesive (so that the adhesive adheres directly onto wetor moist skin). In addition, it is also preferable that the adhesivemaintains its adhesive strength in the presence of excess liquid forexample when the wearer of the device urinates. In particular, the ratioof the peel strength of the adhesive as determined in the test methodsherein should most preferably be maintained at a constant value suchthat the ratio of initial peel strength (P_(DI)) and the final peelstrength (P_(WF)) is from 2:1 to 1:4, preferably from 2:1.25 to 2:4,most preferably from 2.0:1.5 to 2.0:2.5. Typically for disposable humanwaste management devices the initial peel strength for dry and morepreferably also for wet skin should be from 0.1N/cm to 7.0N/cm, 0.1N/cmto 5.0N/cm, preferably from 0.5N/cm to 3.0N/cm.

It is further also preferable that the adhesive in addition tomaintaining its peel strength over a period of time even in the presenceof water also absorbs less than 15%, preferably less than 10%, morepreferably less than 7% water. Whilst not intending to being bound bytheory, it is believed that in order to obtain direct adhesion onto wetskin and maintain constant adhesion performance over a period of wear,even when exposed to excess liquids or high humidity the ability of theadhesive to absorb water needs to be considered. In particular, it hasbeen identified that, not only the absolute ability of the adhesiveneeds to be considered, but also the rate of water absorption in orderto provide an adhesive meeting the above identified performanceparameters.

For example hydrocolloid particle containing adhesives which are knownin the art comprising a 3-dimensional rubber matrix and colloidalabsorbent particles dispersed therein are only able to absorb limitedamounts of water through the colloidal particles themselves and not thematrix itself. In addition the rate at which water is absorbent is slow.Hence these prior art adhesives do not adhere to wet surfaces.

Prior art hydrogel adhesives on the other hand are able to not onlyabsorb large quantities of water but also at a very fast rate. As aresult such adhesives may be able to adhere, to wet surfaces, howeverdue to the combination of fast rate of absorption and large absolutewater uptake, these adhesives loose their adhesive strength rapidly inthe presence of excess water or high humidity.

Accordingly the adhesives of the present invention exhibit both anability to adhere directly to wet skin, by having a minimum absolutewater absorption ability in combination with a rate of absorption suchthat the peel strength remains within defined levels over the period ofwear.

The adhesive is provided with the preferred pattern, typically on thewearer facing surface (23) of the flange (12) of the device (10), as alayer having a thickness or calliper C that is preferably constant. Thelayer can be preferably continuous or alternatively discontinuous, e.g.in form of dots, spirals, or stripes.

Even though adhesives are used like pressure sensitive adhesives onhuman skin hair and mucous tissues, it is understood that the adhesivecompositions could only with difficulty be considered typical pressuresensitive adhesives (referred to as PSA hereinafter) on the basis of themost characteristic Theological behaviours identifying such materials.

In fact as the person skilled in the art of adhesives knows, the mostcharacteristic feature that distinguishes a PSA from other substancesthat can temporarily adhere objects (e.g. water between two glass platescould) is the fact that their rheological parameters and especially theElastic Modulus G′ vary greatly with the frequency of applied stresses.More in particular, G′ of PSA can increase over some orders ofmagnitude, while the frequency of applied stresses varies from typicalbonding frequency to typical debonding frequency, i.e. 1 rad/s to 100rad/s as indicated below.

As a first consequence, it is therefore inadmissible to define materialsintended for use as “adhesives” by giving values of rheologicalparameters and especially of G′ at a fixed value of frequency. This canbe misleading because in the absence of other characteristics such assurface chemistry it will include materials which have no practicalvalue. It is hence necessary that rheological characterisation must beon the basis of dynamic considerations. This not only applies to theElastic Modulus G′ but also to the viscous modulus G″ and hence also fortan (d)=G″/G′.

It is well known that typical PSAs have not only a high variation of G′across the considered frequencies, but also that there is an even highervariation of G″ which can get close or become even higher than the valueof G′, i.e. tan (d) becomes about or even greater than 1, in particularat the frequencies that are typical of debonding.

Without wishing to be bound by theory this can be interpreted as meaningthat a high fraction of the energy applied for the debonding isdissipated within the adhesive (so it is not effective in causing thedebonding) and through the interface of the adhesive and the skin, whilethis fact causes macroscopically the recording of a very high level ofadhesive force.

As indicated above materials useful as adhesives according to thepresent invention have theological characteristics which are measured ata reference temperature of 37° C. (as usual body temperature of humans)and in a range of frequencies. It has been found that upon applicationof a human waste management device with a adhesive the adhesive contactis formed at a low frequency, while debonding happens at the speed ofremoving the device. This speed is expressed as a frequency of 100rad/s, while the low frequency of forming the adhesive bond has beenfound to be on the order of 1 rad/s. Therefore, the frequency range foruse according to the present invention is between 1 and 100 rad/s.

In order to provide good conditions of bonding, i.e. at a frequency ofabout 1 rad/sec, the absolute values of the elastic modulus should notbe too high, otherwise the adhesive is too hard and it is not able tointimately join or mold to the surface to which it is expected toadhere. It is also important to have a low absolute value of G″ in orderto have good cohesion while the material remains soft and capable ofgently adhering to skin.

The ratio of G′₃₇ (1 rad/sec) over G″₃₇ (1 rad/sec) is important toensure that these two values are balanced upon adhesion to the skin.$\frac{{G_{37}^{\prime}( {100\quad {rad}\text{/}\sec} )} - {G_{37}^{''}( {100\quad {rad}\text{/}\sec} )}}{{G_{37}^{\prime}( {1\quad {rad}\text{/}\sec} )} - {G_{37}^{''}( {1\quad {rad}\text{/}\sec} )}}$

needs to be large enough to ensure that the dynamic behaviour of boththe elastic and the viscous module are maintained in a relationshipwhich provides secure adhesion and painless and easy removal.

Finally the person skilled in the art will also recognise that the GlassTransition Temperature Tg of the adhesive composition, the specific heatcapacity, and the specific heat conductivity are parameters which areuseful to more fully define the group of useful adhesives.

The following set of characteristics should preferably be satisfied forthe adhesive of the present invention:

G′₃₇ (1 rad/sec) is in the range 500 Pa to 20000 Pa, preferably 700 Pato 15000 Pa, most preferably 1000 Pa to 10000 Pa. G″₃₇ (1 rad/sec) is inthe range 100 Pa to 15000 Pa, preferably 100 Pa to 10000 Pa, mostpreferably 300 Pa to 5000 Pa. the ratio of G′₃₇ (1 rad/sec)/ is in therange of 1 to 30. G″₃₇ (1 rad/sec) the ratio$\frac{{G_{37}^{\prime}( {100\quad {{rad}/\sec}} )} - {G_{37}^{''}( {100\quad {{rad}/\sec}} )}}{\begin{matrix}{{G_{37}^{\prime}( {1\quad {{rad}/\sec}} )} - {G_{37}^{''}( {1\quad {{rad}/\sec}} )}} \\{{{is}\quad {not}\quad {less}\quad {than}\quad 0.5},{{preferably}\quad {in}\quad {the}\quad {range}}} \\{{0.7\quad {to}\quad 3},{{most}\quad {preferably}\quad {in}\quad {the}\quad {range}\quad 1\quad {to}\quad {1.8.}}}\end{matrix}}$

is not less than 0.5, preferably in the range 0.7 to 3, most preferablyin the range 1 to 1.8.

The value of the ratio of G′₃₇/G″₃₇ at least for the frequency rangeabove 1 rads/up to 100 rads/s should preferably be not less than 0.5,preferably from 0.7 to 10 and most preferably from 1 to 7.

The rheological behaviour can also be related to the values of the GlassTransition Temperature Tg. For topical adhesives according to thepresent invention Tg should preferably be less than 0° C., morepreferably less than −5° C. and most preferably less than −10.

In order to provide adhesive compositions which satisfy the requirementsof the above rheological and physical characteristics of an adhesive anymedically suitable substantially water insoluble pressure sensitiveadhesives comprising a polymer which forms a 3-dimensional matrixmeeting the these characteristics may be utilised.

According to the present invention the 3 dimensional matrix alsoreferred to herein as a gel, comprises as an essential component apolymer which can be physically or chemically cross linked. The polymermay be naturally or synthetically derived. The uncrosslinked polymerincludes repeating units or monomers derived from vinyl alcohols, vinylethers and their copolymers, carboxy vinyl monomer, vinyl estermonomers, esters of carboxy vinyl monomers, vinyl amide monomers,hydroxy vinyl monomers, cationic vinyl monomers containing amines orquaternary groups, N-vinyl lactam monomer, polyethylene oxides,polyvinylpyrrolidone (PVP), polyurethanes, acrylics such as methylacrylate, 2-hydroxyethyl methacrylate, methoxydiethoxyethyl methacrylateand hydroxydiethoxyethyl methacrylate, acrylamides, and sulphonatedpolymers such as acrylamide sulphonated polymers for example 2acrylamido methylpropane sulphonic acid and acrylic (3-sulphopropyl)ester acid, and mixtures thereof. Also acrylonitrile, methacrylamide,N,N,-dimethylacrylamide, acrylic esters such as methyl, ethyl and butylacrylates. Alternatively, the uncrosslinked polymer may be a homopolymeror copolymer of a polyvinyl ether, or a copolymer derived from a halfester of maleic ester. Similarly any other compatible polymer monomerunits may be used as copolymers such as for example polyvinyl alcoholand polyacrylic acid or ethylene and vinyl acetate.

As another alternative, the polymers may be block copolymerthermoplastic elastomers such as ABA block copolymers such asstyrene-olefin-styrene block copolymers or ethylene-propylene blockcopolymers. More preferably such polymers include hydrogenated gradestyrol/ethylene-butylene/styrol (SEBS), styrene/isoprene/styrene (SIS),and styrol/ethylene-propylene/styrol (SEPS).

Particularly preferred polymers are acrylics, sulphonated polymers suchas acrylamide sulphonated polymers, vinyl alcohols, vinyl pyrrolidone,polyethylene oxide and mixtures thereof. Most preferred are nitrogencontaining polymers.

According to the present invention the 3 dimensional adhesive matrixalso essentially comprises a plasticiser, which is preferably a liquidat room temperature. This material is selected such that the polymer maybe solubilized or dispersed within the plasticiser. For embodimentswherein irradiation cross linking is to be carried out, the plasticisermust also be irradiation cross linking compatible such that it does notinhibit the irradiation cross linking process of the polymer. Theplasticiser may be hydrophilic or hydrophobic.

Suitable plasticisers include water, alcohols, polyhydric alcohols suchas glycerol and sorbitol, and glycols and ether glycols such as mono- ordiethers of polyalkylene gylcol, mono- or diester polyalkylene glycols,polyethylene glycols (typically up to a molecular weight of about 600),glycolates, glycerol, sorbitan esters, esters of citric and tartaricacid, imidazoline derived amphoteric surfactants, lactams, amides,polyamides, quaternary ammonium compounds, esters such phthalates,adipates, stearates, palmitates, sebacates, or myristates, andcombinations thereof. Particularly preferred are polyhydric alcohols,polyethylene glycol (with a molecular weight up to about 600), glycerol,sorbitol, water and mixtures thereof.

Typically the adhesive comprises a ratio of polymer to plasticiser byweight of from 1:100 to 100:1, more preferably from 50:1 to 1:50.However, the exact amounts and ratios of the polymer and plasticiserwill depend to a large extent on the exact nature of polymer andplasticisers utilised and can be readily selected by the skilled personin the art. For example a high molecular weight polymer material willrequire a greater amount of plasticiser than a low molecular weightpolymer.

In addition, the adhesive also further preferably comprises alipid-micellising polymer, i.e. a so-called hypercoiling polymer. Thispolymer functions to micellise and remove the rolled up pockets ofgrease from the gel-skin interface.

This hypercoiling polymer has the capability of more effectivelysolvating the primary surfactant micelles that contact hydrophobic skincontaminant such as skin lipid or skin creme. The consequence of thisfunctional role is that the work of adhesion between adhesive and skinis progressively less affected by the presence of either or bothsurfactant or hydrophobic skin contaminant.

The hypercoiling polymer preferably comprises any of the following,either alone or in combination: poly (maleic acid styrene), poly (maleicacid butyl vinyl ether), poly (maleic acid propyl vinyl ether), poly(maleic acid ethyl vinyl ether) and poly (acrylic acid ethyl acrylate).

A particularly preferred example is an alternating copolymer of styreneand maleic anhydride. As discussed herein after the adhesive seeks toprovide a biphasic structure on polymerisation. These two phases arehydrophilic and hydrophobic. The hydrophobic phase may be provided by ahydrophobic monomer which is initially maintained as part of thehomogenous reaction mixture by way of a reactive solvent bridge.Alternatively and/or additionally the hydrophobic component is providedas a polymer which separates from the aqueous phase on polymerisation.

The exact amounts and ratios of the hypercoiling polymer will depend toa large extent on the nature of the components.

In certain circumstances the reaction mixture preferably comprises from3% to 20%, and more preferably from 8% to 18% by weight of the reactionmixture, of a stabilised polymer dispersion that is used to provide astable phase separated system. The polymer preferably comprises any ofthe following either alone or in combination: vinylacetate dioctylmaleate copolymer or ethylene-vinyl acetate copolymer.Ethylene-vinylacetate copolymer is preferred, such as that marketedunder the trade name DM137 by Harlow Chemicals.

The adhesive also preferably comprise surfactants such as nonionic,cationic, anionic, amphoteric and any mixtures thereof.

Suitable nonreactive nonionic surfactants include but are not limited tothose selected from the group consisting of the condensation products ofa higher aliphatic alcohol, such as a fatty alcohol, containing about 8to about 20 carbon atoms, in a straight or branched chain configuration,condensed with about 3 to about 100 moles, preferably about 5 to about40 moles and most preferably about 5 to about 20 moles of ethyleneoxide. Examples of such nonionic ethoxylated fatty alcohol surfactantsare the Tergitol.TM. 15-S series from Union Carbide and Brij.TM.surfactants from ICI. Tergitol.TM. 15-S Surfactants include C.sub.11-C.sub.15 secondary alcohol polyethyleneglycol ethers. Brij.TM 58Surfactant is Polyoxyethylene(20) cetyl ether, and Brij.TM.76 Surfactantis Polyoxyethylene(10) stearyl ether.

Other suitable nonreactive nonionic surfactants include but are notlimited to those selected from the group consisting of the polyethyleneoxide condensates of one mole of alkyl phenol containing from about 6 to12 carbon atoms in a straight or branched chain configuration, withabout 3 to about 100 moles of ethylene oxide. Examples of nonionicsurfactants are the Igepal.TM.CO and CA series from Rhone-Poulenc.Igepal.TM.CO surfactants include nonylphenoxy poly(ethyleneoxy)ethanols. Igepal.TM. CA surfactants include octylphenoxypoly(ethyloneoxy) ethanols.

Another group of usable nonreactive nonionic surfactants include but arenot limited to those selected from the group consisting of blockcopolymers of ethylene oxide and propylene oxide or butylene oxide.

Examples of such nonionic block copolymer surfactants are thePluronic.TM. and Tetronic TM. series of surfactants from BASF.Pluronic.TM. surfactants include ethylene oxide-propylene oxide blockcopolymers. Tetronic.TM. surfactants include ethylene oxide-propyleneoxide block copolymers. Suitable examples are Pluronic L68 and Tetronic1307. Particularly suitable examples are Pluronic L64 and Tetronic 1107.

Still other satisfactory nonreactive nonionic surfactants include butare not limited to those selected from the group consisting of sorbitanfatty acid esters, polyoxyethylene sorbitan fatty acid esters andpolyoxyethylene stearates. Examples of such fatty acid ester nonionicsurfactants are the Span.TM., Tween.TM., and Myrj.TM. surfactants fromICI. Span.TM. surfactants include C.sub.12-C.sub. 18 sorbitanmonoesters. Tween.TM. surfactants include poly(ethylene oxide)C.sub.12-C.sub.18 sorbitan monoesters. Myrj.TM. surfactants includepoly(ethylene oxide) stearates.

Suitable anionic surfactants will normally include a hydrophobic moietyselected from the group consisting of (about C.sub.6 to about C.sub.20)alkyl, alkylaryl, and alkenyl groups and an anionic group selected fromthe group consisting of sulfate, sulfonate, phophate, polyoxyethylenesulfate, polyoxyethylene sulfonate, polyoxyethylene phosphate and thealkali metal salts, ammonium salts, and tertiary amino salts of suchanionic groups.

Anionic surfactants which can be used in the present invention includebut are not limited to those selected from the group consisting of(about C.sub.6 to about C.sub.20) alkyl or alkylaryl sulfates orsulfonates such as sodium lauryl sulfate (commercially available asPolystep.TM B-3 from Srepan Co.) and sodium dodecyl benzene sulfonate,(commercially available as Siponate.TM.DS-10 from Rhone-Poulene);polyoxyethylene (about C.sub.6 to about C.sub.20) alkyl or alkylphenolether sulfates with the ethylene oxide repeating unit in the surfactantbelow about 30 units, preferably below about 20 units, most preferablybelow about 15 units, such as Polystep.TM.B-1 commercially availablefrom Stepan Co. and Alipal.TM.EP110 and 115 from Rhone-Poulenc; (aboutC.sub.6 to about C.sub.20) alkyl or alkylphenoxy poly(ethyleneoxy)ethylmono-esters and di-esters of phosphoric acid and its salts, with theethylene oxide repeating unit in the surfactant below about 30 units,preferably below about 20 units, most preferably below about 15 units,such as Gafac.TM.RE-510 and Gafac.TM.RE-610 from GAF.

Cationic surfactants useful in the present invention include but are notlimited to those selected from the group consisting of quaternaryammonium salts in which at least one higher molecular weight group andtwo or three lower molecular weight groups are linked to a commonnitrogen atom to produce a cation, and wherein theelectrically-balancing anion is selected from the group consisting of ahalide (bromide, chloride, etc.), acetate, nitrite, and loweralkosulfate (methosulfate etc.). The higher molecular weightsubstituent(s) on the nitrogen is/are often (a) higher alkyl group(s),containing about 10 to about 20 carbon atoms, and the lower molecularweight substituents may be lower alkyl of about 1 to about 4 carbonatoms, such as methyl or ethyl, which may be substituted, as withhydroxy, in some instances. One ore more of the substituents may includean aryl moiety or may be replaced by an aryl, such as benzyl or phenyl.

In a particularly preferred embodiment of the invention the surfactantcomprises at least one propylene oxide/ethylene oxide block copolymer,for example such as that supplied by BASF Plc under the trade namePluronic L64. The reaction mixture ideally comprises form 0.1% to 5%, byweight of the reaction mixture, of surfactant.

The surfactant acts to remove the grease from the skin and to form theremoved grease into isolated pockets within the hydrogel withoutreducing the work of adhesion of the coating.

Other common additives known in the art such as preservatives,antioxidants, pigments, mineral fillers and mixtures thereof may also becomprised within the adhesive composition in quantities up to 10% byweight each respectively.

According to the present invention the polymer component of the adhesivecan be physically or chemically cross-linked in order to form the 3dimensional matrix. Physical cross linking refers to polymers havingcross links which are not chemical covalent bonds but are of a physicalnature such that there are areas in the 3 dimensional matrix having highcrystallinity or areas having a high glass transition temperature.Chemical cross-linking refers to polymers which are linked by chemicalbonds. Preferably the polymer is chemically cross-linked by radiationtechniques such as thermal-, E beam-, UV-, gamma or micro-waveradiation.

In addition when chemical crosslinks are formed in the system, apolyfunctional cross linker and/or a free radical initiator may bepresent in the premix to initiate the crosslinking upon irradiation.Such an initiator can be present in quantities up to 5% by weight,preferably from 0.02% to 2%, more preferably from 0.02% to 0.2%.Suitable photoinitiators include type I-α-hydroxy-betones andbenzilidimethyl-betols e.g. Irgocure 651 which are believed to onirradiation to form benzoyl radicals that initiate polymerization.Particularly preferred is I-hydroxycyclohexylphenylketone (availableunder the trade name Irgacure 184 from Ciba Speciality Chemicals). Inaddition from 0.02% to 2% of thermal initiators may also be used.

The resulting adhesive composition is mainly hydrophilic. Hydrophobicand mixed phase compositions are dependant upon the nature of thecomponents of the adhesive. In addition a mixture of monomers whetherhydrophilic or both hydrophilic and hydrophobic may result in a singlephase or mixed phase of at least 2 phases. Preferably, the adhesives ofthe present invention are mixed phase hydrophilic hydrophobic.

A mixture of monomers which may result in 1, 2 or more phases arepreferred. Mixed phase adhesives are compositions in which bothhydrophobic and hydrophilic components, preferably in both plasticisersand polymers, form two or more separate phases. In such cases anemulsifier is preferably present at a suitable level to form stableemulsions between the incompatible phases.

Whilst not intending to be bound by theory it is believed that theimproved peel strength liquid stability particularly with respect towater of the adhesives is obtained from a monomer mix comprising bothhydrophilic e.g. polar and/or ionic monomers preferably an ionic watersoluble monomer and hydrophobic i.e nonionic monomers. Preferably theratio of hydrophilic monomers to hydrophobic monomers should be in therange of from 5:1 to 1:5, preferably from 3:1 to 1:3, more preferablyfrom 2:1 to 1:2. The hydrophilicity and hydrophobicity of a monomercomponent is always relative to the other component. Typically prior arthydrogel adhesives comprise hydrophilic monomers only, as a consequenceof which they have a high rate of water absorption and do not maintainadhesion after exposure to excess liquid. Whilst not intending to bebound by theory, it is believed that the presence of a hydrophobiccomponent in the adhesive matrix reduces the rate of absorption of waterof the adhesive. As a result the distribution of the water absorbed bythe adhesive is more uniform. Consequently a water film is not generatedbetween the surface of the skin and the adhesive, which if present,prevents the formation of bonds between skin and adhesive and thus theadhesive capacity of the adhesive itself.

Thus the invention seeks to provide a homogeneously dispersed reactionmixture comprising both hydrophobic and hydrophilic components which, onpolymerisation separates into a biphasic or a multiphasic structure. Thephases have in some cases been observed to have a thickness of about 100microns +/−50 microns. The reaction mixture may contain one or moresurface active agents which may assist or promote phase separation butin the course of polymersation become anistropically distributed betweenthe result phases.

The presence of a hydrophobic monomer or polymer may be necessary in theinitial homogenous dispersion in order to more effectively promote phaseseparation.

It is a consequence of this invention that the phase separated materialcontains relatively hydrophobic regions, which enable the polymer tofunction as a pressure sensitive adhesive, and substantially hydrophilicregion, which enable the surface active agent to function in an aqueousenvironment at the interface between the polymer and mammalian skin.When the polymer is placed in contact with skin, the nature and quantityor surface active agent are chosen to bring about the removal of naturalor synthetic hydrophobic material, such as skin lipid or skin creme,from the skin surface without adversely diminishing the work of adhesionbetween the hydrophobic domains and the skin surface. In as much as boththe polymeric adhesive formed in this invention and the skin with whichit is contacted are deformable under conditions of normal use, anequilibrium interfacial situation is reached in which some spatialexchange of hydrophobic regions and hydrophobic regions will have takenplace on the skin surface.

Suitable preferred hydrophilic monomers are acrylic acid, and saltsthereof, 2-acrylamido methylpropane sulphonic acid, acrylic(3-sulphopropyl) ester acid and salts thereof and combinations thereof.Suitable hydrophobic monomer components are acrylamide, acrylonitrile,methyl-, ethyl-, butyl hexyl, iso octyl- and isodecyl acrylates andmethacrylate, vinyl ethers, vinyl pyrrolidine, gylcidyl acrylate and2-hydroxyethyl acrylate, tehra-hydrofurfuryl acrylate, hydroxypropylacrylate, vinyl propionate and vinyl butyrate, and combinations thereof.Particularly preferred are ethoxy ethyl acrylate or butyl acrylate.

When the adhesive comprises a hydrophobic component, such as butylacrylate as well as a hydrophilic monomer (i.e. the aforesaid watersoluble ionic monomer), such as NaAMPS, the nonionic water solublemonomer, for example NNDMA, acts as a so-called “reactive solventbridge” to provide intimate mixing of the various seemingly incompatiblecomponents of the reaction mixture prior to polymerisation. The reactionmixture thus has a homogenous structure containing both hydrophilic andhydrophobic components that are intimately mixed, as the NNDMA acts as asolvent for both hydrophilic and hydrophobic materials, providing aclear compatible coating solution or dispersion. As the reactive solventbridge is polymerised and thus essentially removed from the reactionmixture the stability of the system is adversely affected and thecompatible coating solutions or dispersions undergo phase separation soas to provide a biphasic structure.

In preparing adhesive compositions in accordance with the invention, theingredients will usually be mixed to provide a reaction mixture in theform of an initial pre-gel aqueous based liquid formulation, and this isthen converted into a gel by a free radical polymerisation reaction.This may be achieved for example using conventional thermal initiatorsand/or photoinitiators or by ionizing radiation. Photoinitiation is apreferred method and will usually be applied by subjecting the pre-gelreaction mixture containing an appropriate photoinitiation agent to UVlight after it has been spread or coated as a layer on siliconisedrelease paper or other solid substrate. The incident UV intensity, at awavelength in the range from 240 to 420 nm, is ideally substantially 40mW/cm². The processing will generally be carried out in a controlledmanner involving a precise predetermined sequence of mixing and thermaltreatment or history.

The UV irradiation time scale should ideally be less than 60 seconds,and preferably less than 10 seconds to form a gel with better than 95%conversion of the monomers and for conversion better than 99.95%exposure to UV light less than 60 seconds and preferably less than 40seconds is preferred. Those skilled in the art will appreciate that theextent of irradiation will be dependent on the thickness of the reactionmixture, concentration of photoinitiator and nature of substrate on towhich the reaction mixture is coated and the source of UV.

These timings are for medium pressure mercury arc lamps as the source ofUV operating at 100 W/cm. The intensity of UV@254 nm and 313 nm reachingthe surface of the substrate is approximately 150 μW/cm² and 750 μW/cm².For a given lamp UV intensity in a function of the operating power anddistance of the reaction mixture from the UV source.

In order to minimize and preferably eliminate the presence of anyresidual monomers it is important to ensure that the reaction iscomplete. This is dependent upon a number of factors such as thesubstrate onto which the adhesive is applied, the type and intensity ofthe ultra violet light and the number of ultra violet light passes.Preferably the conversion of the hydrophilic monomers present such asNaAMPS should be 98%, preferably 99.0% most preferably 99.9% so that theamount of monomer within the adhesive is 4600 microg/g or less,preferably 2300 microg/g or less, most preferably 230 microg/g or less.Similarly, the conversion of the hydrophobic monomers present such asNNDMA should be 99%, preferably 99.9%, most preferably 99.99% so thatthe amount of monomer present in the adhesive is 2200 microg/g or less,preferably 220 microg/g or less, most preferably 22 microg/g or less.

The adhesive is thus typically formed by polymerising an aqueousreaction comprising from 5 to 50%, preferably form 30% to 50% by weightof the reaction mixture, of hydrophilic monomer, i.e. an ionic watersoluble monomer, from 10% to 50%, preferably from 15% to 45% by weightof the reaction mixture, of a plasticiser (other than water), from 10%to 50%, preferably from 15% to 30% more preferably from 15% to 25% byweight of the reaction mixture, of a hydrophobic nonionic monomer, i.e.nonionic water soluble monomer, from 3 to 40%, by weight of the reactionmixture, of water. If present the reaction mixture comprises from to10%, by weight of the reaction mixture, of a surfactant. Similarly thereaction mixture may also comprise from 0.1% to 5%, by weight of thereaction mixture, of a lipid micelling polymer.

The adhesive is provided, typically on at least a portion of the wearerfacing surface of the flange, as a layer having a thickness or calliperC that is preferably constant, or that alternatively can vary over thesurface of application of the adhesive.

When considering particularly the removal phase of an adhesivecomposition for attachment to the skin of a wearer, it is commonlyrecognised that good conditions of removal, i.e. at a frequency of about100 rad/sec, of the adhesive applied to at least part of the wearerfacing surface of the flange, are achieved when the adhesive can beeasily removed from the skin, and particularly from the bodily hair thatmay be located on this area of the skin, where the flange contacts thebody, without causing pain to the wearer, therefore without adhering toohard upon removal, to the skin and the hair of the wearer. Moreover, agood removal implies that the adhesive does not leave residues on theskin or on the hair.

The relationship between the thickness or calliper C measured inmillimeters (mm) of the layer of the adhesive typically onto at leastpart of the wearer's facing surface of the flange of the disposablehuman waste management device, and the viscous modulus G″₂₅ at 25° C. atabout 100 rad/sec of the topical adhesive gives an indication ofpainless and easy removal of the adhesive from the skin.

Without being bound to any theory, it is believed that for higher valuesof G″₂₅ at 100 rad/sec, which overall correspond to a higheradhesiveness of the composition, a thicker calliper or thickness C ofthe adhesive layer is needed so that the energy applied for the removalis more evenly distributed within the mass of the adhesive, and istherefore transferred smoothly to the skin, so avoiding peaks of energythat typically cause the pain sensation to the wearer. In other words,thinner layers of the adhesive necessitate an adhesive with a lower G″₂₅at 100 rad/sec to achieve a reduced pain sensation upon removal of thedevice.

According to the present invention, the adhesive is preferably providedas a layer having a thickness C such that the viscous modulus G″₂₅ (100rad/sec) and the thickness C of the adhesive layer satisfy the followingempirical equation:

G″ ₂₅ ≦[(7.00+C)×3000]Pa

and preferably the following empirical equation:

G″ ₂₅≦[(5.50+C)×1700]Pa

While in a preferred embodiment of the present invention the thickness Cof the adhesive layer is constant, such an adhesive layer can also havedifferent thicknesses in different portions of the wearer facing surfaceof the flange where it is applied, provided that the above mentionedrelationship between C and G″₂₅ is in any case satisfied in eachportion.

According to the present invention any disposable human waste managementdevice known in the art can be provided with the adhesive according tothe present invention as defined herein.

Typically urine or faecal management devices (10) comprise a bag (11)having an aperture (21) and a flange (12) surrounding the aperture forpreferably adhesive attachment to the uro genital area and or theperianal area of a wearer as visible from FIGS. 1 and 4. Any faecal orurine management device known in the art can be provided with anadhesive according to the present invention.

The bag (11) as used herein is a flexible receptacle for the containmentof urine and excreted faecal matter. The bag (11) can be provided in anyshape or size depending on the intended use thereof, i.e. whether thedevice is intended for bedridden patients or active patients sufferingfrom incontinence or requiring an artificial bowel or for infants. Forexample, elongated bags which are principally tubular or rectangular aretypically utilised by bedridden patients and elderly incontinencesufferers. For more active wearers whether infants or adults, thedisposal human waste management device should preferably be anatomicallyshaped such that the device follows the contours of the body and can beworn inconspicuously by the wearer under normal garments.

Particularly, preferred shapes are flat circular type bags, cone shapedbags, truncated shaped bags and pyramidal or truncated pyramidal shapedbags. In a most preferred embodiment of a faecal management device ofthe present invention, the bag (11) has a substantially truncated coneshape. A preferred shape bag for urine devices is shown in FIG. 4.Typically the bags will have a wearer facing portion (16) and a garmentfacing portion (17). The wearer facing portion (16) of the faecalmanagement device (10) is disposed adjacent the buttocks of the wearer.As such, the wearer facing portion (16) amply covers the buttocks of thewearer and does not hang between the thighs of the wearer.

In addition, the bag (11) is preferably shaped to allow at least partialinsertion and retention of the bag in-between the buttocks of the wearerand thereby ensure good contact between the flange and the skin of thewearer. For example, the bag (11) may be provided with a neck portion orconduit.

The bag (11) is preferably designed to provide sufficient volume forurine and/or faecal material under a variety of wearing conditions, alsowhen worn by a freely moving, i.e. not bedridden wearer. Sitting on thebag, for example, will result in a largely reduced volume in some areasof the bag. Thus, the bag (11) is preferably shaped to providesufficient volume in areas which are not subjected to much pressure inwearing conditions such as sitting.

The bag (11) is designed to safely contain any entrapped material,typically it will be liquid impermeable, yet it may be breathable. Thebag (11) is designed of sufficient strength to withstand rupture in use,also when pressure on the bag (11) is exerted in typical wearingconditions, such as sitting.

According to the present invention, depending on the shape of the bag(11) required, the bag (11) may be provided from a unitary piece ofmaterial or from a number of separate pieces of material, which may beidentical or different and which are sealed at their respectiveperipheries.

In one preferred embodiment the bags herein have a wearer facing portion(16) and a garment facing portion (17) which comprise separate pieces ofmaterial. The wearer facing portion (16) and the garment facing portion(17) are sealed at the periphery of the bag (11), thus creating a bagperipheral rim (18). As is visible from FIG. 1, the wearer facingportion (16) of the bag (11) may comprise two further sections (19),which are secured to each other by means known to the man skilled in theart, such as adhesive, thermobonding or pressure bonding in order toprovide the desired bag configuration. Said rim (18) may also be insidethe bag, thus being coextensive with the inner surface (15) of the bag(11) rather than with the outer surface (30) of the bag (11). Preferablythe bag (11) is asymmetrical to the transversal axis, so that thedistance measured in the longitudinal direction from the centre of theaperture (21) to the front end of the bag (11) is shorter than thedistance measured to the rear end of the bag (11).

According to the present invention the bag (11) can comprise one ormultiple layers, preferably two or three layers. The layer on the insideof the bag (11), which will typically at least partially come in contactwith faecal material is called the inner layer. The outermost layer ofthe bag, which will typically at least partially come in contact withthe skin to the wearer and the garments of the wearer, is called theouter layer.

The layers of the bag material may be provided from any material,preferably so that the bag is liquid impervious. The layers may inparticular comprise any material such as non-wovens or films. In apreferred embodiment of the present invention a laminate may be formedfrom a non-woven layer and a film. The laminate can be formed by meansknown to the man skilled in the art.

Any non-woven layer can comprise felt fabrics, spunlaced fabrics, fluidjet entangled fabrics, air-laid fabrics, wet-laid fabrics, dry-laidfabrics, melt-blown fabrics, staple fibre carding fabrics, spunbondedfabrics, stitch-bonded fabrics, apertured fabrics, combinations of theabove or the like.

Suitable film materials for any of said layers preferably comprise athermoplastic material. The thermoplastic material can be selected fromamong all types of hot-melt adhesives, polyolefins especiallypolyethylene, polypropylene, amorphous polyolefins, and the like;material containing meltable components comprising fibres or polymericbinders including natural fibres such as cellulose—wood pulp, cotton,jute, hemp; synthetic fibres such as fibreglass, rayon, polyester,polyolefin, acrylic, polyamid, aramid, polytetrafluroethylene metal,polyimide; binders such as bicomponent high melt/low melt polymer,copolymer polyester, polyvinyl chloride, polyvinyl acetate/chloridecopolymer, copolymer polyamide, materials comprising blends wherein someof the constituent materials are not meltable; air and vapour permeablematerials including microporous films such as those supplied by EXXONChemical Co., III, US under the designation EXXAIRE or those supplied byMitsui Toatsu Co., Japan under the designation ESPOIR NO; and monolithicbreathable materials such as Hytrel™ available from DuPont and Pebax™available from ELF Atochem, France.

In a preferred embodiment a film, which is comprised in any layer, ispreferably permeable to gases such as air and to vapour such as watervapour in order to avoid the problem of entrapment and condensation ofmoisture vapour given off by the body of the wearer and thus, the hot,clammy and uncomfortable conditions after a short period of use.

The outer layer of the bag is preferably provided with a non-wovenlayer. Such material layers present an uneven surface to the skin of thewearer and thus reduce significantly the problem of occlusion andgreatly improve skin healthiness.

In one preferred embodiment of the present invention the bag comprisestwo layers. Preferably the outer layer comprises a non-woven layer andthe inner layer comprises a film.

In yet another preferred embodiment of the present invention, the bag(11) comprises three layers, preferably one film and two non-wovenlayers. In an even more preferable embodiment the film is interposedbetween the two non-woven layers. This sequence of layers results in aclosed fibrous structure, which has a particularly pleasing sensation oncontact with the skin of the wearer. In yet another preferred embodimentthe inner layer comprises a film and the other two layers comprisenon-wovens.

The non-woven layer or the non-woven layers comprised by the bag (11)may be hydrophobic or hydrophilic. If the bag (11) does not comprise afilm layer, preferably at least one non-woven layer is hydrophobic. As aconsequence, fluid penetration is resisted through the wearer facingportion (16) and the garment facing portion (17) of the faecalmanagement device (10). If the bag comprises a film or a hydrophobicnon-woven layer, further non-woven layers may be hydrophilic.

Typically, the non-woven layer is treated with a surface activematerial, such as a fluorchemical or other hydrophobic finishings, toprovide the requisite hydrophobicity. The non-woven layer, however, mayequally be treated with coatings of liquid impervious materials such ashot-melt adhesives or coatings of silicone or other hydrophobiccompounds such as rubbers and vegetable and mineral waxes or it may bephysically treated using nano-particulates or plasma coating techniques,for example.

The non-woven layer can also be treated with agents to improve thetactile perceivable softness of the wearer facing portion (16) and thegarment facing portion (17). The agents include but are not limited tovegetable, animal or synthetic oils, silicone oils and the like. Thepresence of these agents are known to impart a silky or flannel-likefeel to the non-woven layer without rendering it greasy or oily to thetactile sense of the wearer. Additionally, surfactant material,including anionic, nonionic, cationic and amphotene surfactants, may beadded to further enhance softness and surface smoothness.

Furthermore, the non-woven layer may be impregnated with a lotion toprovide desirable therapeutic or protective coating lotion benefits. Thelotion coating on the wearer facing portion (16) and the garment facingportion (17) is transferable to the skin of the wearer by normal contactand wearer motion and/or body heat. Generally, mineral oil in the formof a lotion is recognised as being effective in imparting a soothing,protective coating to the skin of the wearer. It is also possible toimpregnate the non-woven layer with a solid oil phase of creamformulation or to incorporate into the non-woven layer an array ofpressure- or thermal- or hydrorupturable capsules containing forexample, baby oil.

In one embodiment of the present invention the bag (11) may containabsorbent material. The absorbent material may comprise any absorbentmaterial which is capable of absorbing and retaining liquids. Theabsorbent material may comprise a wide variety of liquid-absorbentmaterials commonly used in disposable diapers and other absorbentarticles such as comminuted wood pulp, which is generally referred to asairfelt. Examples of other suitable absorbent materials include crepedcellulose wadding; meltblown polymers, including coform; chemicallystiffened, modified or cross-linked cellulosic fibers; tissue, includingtissue wraps and tissue laminates; absorbent foams; absorbent sponges;superabsorbent polymers; absorbent gelling materials; or any other knownabsorbent material or combinations of materials.

The absorbent material may be positioned in the bag (11) in any suitablemanner. For example, the absorbent material may be loosely arrangedwithin the bag or may be secured to the inner layer of the bag (11). Anyknown techniques for securing absorbent material to nonwoven and filmsubstrates may be used to secure the absorbent material to the innerlayer of the bag. The absorbent material may also be arranged to haveany desired shape or configuration (e.g., rectangular, oval, circular,etc.).

In the embodiment shown in FIG. 4, the outer surface of bag (11) isprovided with patches of adhesive (40) for securing the bag (11) to thebody of the wearer. Preferably, the patches of adhesive (40) arepositioned on the outer surface of bag (11) such that they are securedto the abdomen of the wearer in use. Any number, size and shape ofadhesive patches (40) may be used depending on the intended use of thedevice.

The human waste management device in particular urine management devicesaccording to the present invention also preferably comprise anadditional acquisition layer. The acquisition layer is typically securedto the inner surface of bag. However, the acquisition layer may also besecured to the flange, or both the flange and the inner surface of bag.The acquisition layer is preferably positioned such that it separatesthe genitalia of the wearer from coming into direct contact with theabsorbent material. The acquisition layer is fluid pervious allowingurine to readily pass through so that it may be absorbed by absorbentmaterial.

The acquisition layer may be manufactured from a wide range ofmaterials, such as porous foams; reticulated foams; apertured plasticfilms; or woven or nonwoven webs of natural fibers (e.g., wood or cottonfibers), synthetic fibers (e.g., polyester or polypropylene fibers), ora combination of natural and synthetic fibers. If the acquisition,barrier layer includes fibers, the fibers may be spunbond, carded,wet-laid, meltblown, hydroentangled, or otherwise processed as is knownin the art.

The acquisition layer is designed to have a pore size such that theabsorbent material is not allowed to pass through and contact thewearer's skin. While designed not to have to large of a pore size whichpermits the passage of absorbent material, the acquisition layerpreferably has a pore size which is greater than the pore size of theabsorbent material.

Preferably, the acquisition layer is less hydrophilic than the absorbentmaterial. The acquisition layer may be treated with a surfactant toincrease its initial wettability. When treated with surfactant, however,the acquisition layer should still be less hydrophilic than theabsorbent material. Suitable methods for treating the acquisition layerwith a surfactant include spraying the acquisition layer with thesurfactant and immersing the material into the surfactant.Alternatively, a surfactant may be incorporated into the acquisitionlayer.

As shown in FIG. 1 the bag (11) is provided with an aperture (21)whereby excreted matter is received from the body prior to storagewithin the bag cavity. The aperture (21) is surrounded by a flange (12)and may be provided in any shape or size, such as circular, oblong,heart shaped and may be symmetrical or asymmetrical, preferably theaperture has an oblong configuration either in the longitudinal or inthe transversal direction or in both directions, e.g. the contours ofthe aperture are in the shape of two ellipses with the respective mainaxes being substantially perpendicular.

The flange (12) is attached to the bag (11) according to any means knownto the man skilled in the art which may provide permanent or releasableattachment. Preferably however, the flange is attached to the bag byadhesive. Typically, the bag will be attached to the flange, towards theouter periphery of flange so as not to cause any obstruction for theentering matter.

The flange may be provided in any size depending on the wearer group forwhich the device is intended. Similarly the flange may be provided inany shape and preferably has a symmetrical shape preferably comprising aplurality of lobes (13). The flange (12) may comprise a front projection(28) and a rear projection (29) to the perineal and coccygeal area of awearer.

The flange comprises a garment facing surface (22) and a wearer facingsurface (23). In an preferred embodiment these are two large,substantially flat surfaces, however, the flange may also compriseprojections designed to fit the perineal or coccygeal area of thewearer.

The flange (12) should be made of soft, flexible and malleable materialto allow easy placement of the flange to the perianal area. Typicalmaterials include nonwoven materials, wovens, open celled thermoplasticfoams, closed-cell thermoplastic foams, composites of open celled foamsand stretch nonwoven, and films. A closed-cell foam of polyethylene hasbeen found effective, but more preferably an open celled polyurethanefoam is used. Preferably, such foams have a thickness within the generalrange of 0.1 to 5 millimeters and a density of 5 to 250 g/m², morepreferably 50 g/m². Other thermoplastic foam materials, or othersuitable plastics sheet materials having the described properties ofsuch foams (i.e., softness, pliability, stretchability, andcontractability) might also be used. Preferably, the material of garmentfacing surface (23) of the flange (12) may extend into the definedaperture area so as to form a skirt or flap of material which preventsunintentional adhesion of the surface edges of the flange defining theaperture to oneanother during use.

According to the present invention the adhesive (20) is preferablycovered with a release means (not shown) in order to protect theadhesive (20), such as siliconized paper. The adhesive (20) can coverthe entire wearer facing surface (23) of the flange (12) or morepreferably have at least one, preferably two to six non-adhesiveportions. These portions may be adhesive free or may contain inactivatedor covered adhesives. As is evident from FIG. 1, the adhesive is in onepreferred embodiment not applied to the entire wearer facing surfacearea of the flange (12), so as to provide lobes (13) on either side ofthe flange (12) which are non-adhesive and can thereby serve tofacilitate placement and removal of the device whilst avoiding contactwith the adhesive. These lobes are however preferably also covered bythe release means. Before application of the faecal management device(10) to the skin of the wearer, the release means if present is removed.

The adhesive (20) can be applied to the wearer facing surface of theflange (12) by any means known in the art such as slot coating, spiral,or bead application or printing. Typically the adhesive is applied at abasis weight of from 20 g/m² to 2500 g/m², more preferably from 500 g/m²to 2000 g/m² most preferably from 700 g/m² to 1500 g/m² depending on theend use envisioned. For example, for faecal management devices (10) tobe used for babies the amount of adhesive may be less than for faecalmanagement devices (10) designed for active adult incontinencesufferers.

The disposable human waste management device (10) of the presentinvention has been found to be particularly useful and beneficial whenused in conjunction with a garment, or diaper (50), preferably adisposable diaper—refer to FIG. 2. The disposable human waste managementdevice (10) is preferably first positioned in the perianal area of thewearer before the disposable diaper (50) is applied. In particular, thediaper (50) is positioned over the disposable human waste managementdevice (10) and fastened in a conventional manner around the body of thewearer. It has been found that, in addition, to providing excellentseparation between urine and faecal material, the combined disposablehuman waste management device (10) and diaper (50) system actuallyreduces skin irritation, which may at times occur, especially since thegroup of typical wearers includes the very old, the very young and theunhealthy wearers. In effect, the presence of the disposable human wastemanagement device (10) permits the formation of a separation layerbetween the skin of the wearer and the diaper (50), i.e. a part of theabsorbent core (58) of the diaper (10). The diaper (50) can be of theconventional type (an embodiment of which is described below althoughnot a limiting example by any means) or can be adapted to contain in aneffective and comfortable manner the disposal human waste managementdevice (10) according to the teachings of the present invention.

As used herein, the term “disposable diapers” refers to articles whichabsorb and contain body extrudates; and more specifically, refers toarticles which are placed against or in proximity to the body of thewearer to absorb and contain the various extrudates discharged from thebody and which are intended to be discarded after a single use (i.e.,they are not intended to be laundered or otherwise restored or reused)and, preferably, to be recycled, composted or otherwise disposed of inan environmentally compatible manner. As used herein, the term “diaper”refers to a garment generally worn by infants or incontinence sufferersthat is drawn up between the legs and fastened about the waist of thewearer.

FIG. 3 is a partially cut-away perspective view of a diaper (50)embodying the present invention prior to it being placed on the wearerover the faecal management device (10). As is visible from FIG. 3, apreferred diaper (50) comprises a body portion (52) and a refastenablemechanical fastening device (54). A preferred body portion (52)comprises a liquid pervious topsheet (56), and absorbent core (58), aliquid impervious backsheet (60), and elastically contractible leg cuffs(62); each leg cuff (62) preferably comprising a side flap (64) and oneor more elastic members (66). For simplicity purposes, only one elasticmember (66) is shown in the side flap (64). While the topsheet (56), theabsorbent core (58), the backsheet (60), the side flaps (64), and theelastic members (66) may be assembled in a variety of well-knownconfigurations. A preferred disposable diaper configuration is shown andgenerally described in U.S. Pat. No. 3,860,003, an even more preferreddisposable diaper configuration is shown and generally described in WO93/16669. In this preferred diaper configuration, the backsheet (60) isjoined to the topsheet (56); the absorbent core (58) is positionedbetween the topsheet (56) and the backsheet (60); the side flaps (64)extend outwardly from and along each side edge of the absorbent core(58); and the elastic member (66) is operatively associated with eachside flap (64).

FIG. 3 shows the body portion (52) in which the topsheet (56) and thebacksheet (60) are coextensive and have length and width dimensionsgenerally larger than those of the absorbent core (58). The topsheet(56) is superposed on the backsheet (60) thereby forming the periphery(68) of the body portion (52).

The body portion (52) has an inside surface (74) and an outside surface(76). When a backsheet (60) is used, it typically forms the outsidesurface (76) of the body portion (52). The inside surface (74) is thatsurface of the diaper (50) opposite the outside surface (76) and in theembodiment shown is typically formed by the topsheet (56). In general,the inside surface (74) of the diaper (50) is that surface coextensivewith the outside surface (76) and which is for the greater part incontact with the wearer when the diaper (50) is worn.

The absorbent core (58) of the body portion (52) may be any absorbentmeans which is generally compressible, conformable, non-irritating tothe skin of the wearer, and capable of absorbing and retaining liquidssuch as urine and other certain bodily discharges. The absorbent core(58) may be manufactured in a variety of sizes and shapes (for example,rectangular, hour-glass, “T”-shaped, asymmetric, etc.) and from a widevariety of liquid absorbent materials commonly used in disposablediapers and other absorbent articles such as comminuted wood pulp whichis generally referred to as airfelt. Examples of other suitableabsorbent materials include creped cellulose wadding, meltblown polymersincluding coform, crosslinked cellulosic fibers, tissue including tissuewraps, absorbent foams, absorbent sponges, superabsorbent polymers,absorbent gelling materials, or any equivalent materials or combinationsof materials. The configuration and construction of the absorbent core(58) may also be varied (for example, the absorbent core (58) may havevarying calliper zones, hydrophilic gradients, superabsorbent gradients,or lower average density and lower average basis weight acquisitionzones; or may comprise one or more layers or structures). Further, thesize and absorbent capacity of the absorbent core (58) may be varied toaccommodate wearers ranging from infants to adults.

The backsheet (60) is impervious to liquids (for example, urine) and ispreferably manufactured from a thin plastic film, preferably athermoplastic film, although other flexible liquid impervious materialsmay also be used. As used herein, the term “flexible” refers tomaterials which are compliant and which will readily conform to thegeneral shape and contours of the human body. The backsheet (60)prevents the exudates absorbed and contained in the absorbent core (58)from soiling articles which are in contact with the diaper (50) such asundergarments and bedding. The backsheet (60) may thus comprisepolymeric films such as thermoplastic films of polyethylene orpolypropylene, or composite materials such as film-coated non-wovenmaterial. Exemplary films are manufactured by Tredegar Industries, Inc.of Terre Haute, Ind., USA or BP-Chemical PlasTec, Rotbuchenstrasse 1,D-8000 München, Germany.

The backsheet (60) is preferably textured to provide a more clothlikeappearance. Further, the backsheet (60) may also permit vapours toescape from the absorbent core (58) while still preventing exudates frompassing through the backsheet (60) by, for example, being supplied withmicroapertures. The size of the backsheet (60) is dictated by the sizeof the absorbent core (58) and the exact diaper design selected.

The topsheet (56) of the diaper is compliant, soft feeling andnon-irritating to the skin of the wearer. Further, the topsheet (56) isliquid pervious permitting liquids (for example, urine) to readilypenetrate through its thickness. A suitable topsheet (56) may bemanufactured from a wide range of materials, such as porous foams,reticulated foams, apertured films; or woven or non-woven webs ofnatural fibres (for example, wood or cotton fibres) or from acombination of natural and synthetic fibres. Preferably, it is made of amaterial that isolates the skin of the wearer from liquids retained inthe absorbent core (58).

There are a number of manufacturing techniques which may be used tomanufacture the topsheet (56). For example, the topsheet (56) may be anon-woven web of fibres. An exemplary topsheet (56) is carded andthermally bonded by means well-known to those skilled in the fabric art.A suitable topsheet (56) is manufactured by, for example, Veratec Inc.,a division of International Paper Company, of Walpole, Mass., USA. Atopsheet (56) particularly preferred for incontinence garments comprisesa formed thermoplastic film.

Test Methods Peel adhesion method This is a quantitative method todetermine the average peel force required to remove a skin at aspecified peel angle and speed. Equipment Scissors Convenient sourceStandard ruler Convenient source Steel Roller 5.0 kg Mass. 13 cm indiameter and 4.5 cm in width covered with 0.5 mm thick rubber. PolyesterFilm PET 23μ available from EFFEGIDI S.p.A., 43052 Colorno, Italy.Transfer Adhesive 3M 1524 available from 3M Italia S.p.a., 20090 SegrateItaly Stop watch Convenient source Tensile Tester Instron mod.: 6021 (orequivalent) Test procedure A) Tensile Tester Peel Settings: Load cell 10N Test Speed 1000 mm/min Clamp to Clamp distance 25 mm Pre Loading 0.2 NTest Path “LM” 50 mm Measure variable F average (N) in “LM”

B) Skin Condition and Preparation

The sample is peel from the forearm. There are 3 conditions of the skinthat are tested:

1) Dry: The forearm is untreated and not wiped prior to test or betweenrepetitions.

2) Wet: To one cotton disk (Demak'up diameter 5.5 cm, weight about 0.6g), 3 ml of distilled water is added. Next the disk is then wiped with alight pressure 3 times over the test area on the forearm. (The test areaof the forearm is a rectangle approximately 2 cm wider and longer thanthe adhesive area).

3) Greasy: To one cotton disk (Demak'up diameter 5.5 cm, weight about0.6 g), 4 drops (about 0.2 g) of ‘Nivea Body’ are added. The disk isthen folded in on itself to ensure the cream is absorbed. Next the diskis then wiped with a light pressure 3 times over the test area on theforearm. (The test area of the forearm is a rectangle approximately 2 cmwider and longer than the adhesive area).

C) Sample Preparation

1. Allow the samples to adjust to conditioned room (23±2° Celsius and50±2%RH) for about 1 hr.

2. Prepare rectangular adhesive samples 260 mm±2 length and 20 mm±2wide.

3. Attach on the sample surface the polyester film (using the transferadhesive to attach the polyester to the substrate surface).

4. Each test specimen should be prepared individually and testedimmediately.

5. Remove the release paper from the adhesive without touching it.Attach one end to the skin (see section B).

6. Roll the Steel Roller for 160 mm along the adhesive strip, once ineach direction.

D) Test Environment

There are 2 environments the adhesive can be tested in:

1) Conditioned Room as described in C1.

2) Wet Environment. Here, after step C4, the specimen is taken and putin a humidity controlled oven for 3 hours at 85 deg C. It is then takenout and steps C5, C6 are carried out.

E) Execution

1 minute after Step C6, take the free end of the specimen (approx. 100mm long) and insert it in the upper end of the adhesion testing machine.Ensure the specimen is at a 90 degree angle to the forearm. Start thetesting machine.

F) Report

Report the average of the peel strength of 5 tests. The single valuesare the base to calculate the standard deviation between the samples.

Residual Monomer Test Method

Test Sample

1 gram of a hydrogel sample is taken and emersed in 100 ml 0.9% salinewater. The sample is left in the saline at 40 deg C, for 24 hours. Analiquot of the liquid is diluted and analysed by electrospray LC/MS/MS.

Calibration Sample

1 gram of reference monomers (eg NaAmps) are dissolved in 100 ml 0.9%saline water. An aliquot of the liquid is diluted and analysed byelectrospray LC/MS/MS.

Evaluation

The concentration of the test and calibration sample are determined bylinear regression analysis using a software package such as VG MassLynx.

EXAMPLES

All formulations detailed below were coated onto polyurethane foam(EV1700X from Caligen) at a coat weight of 0.8 to 1.6 kg per squaremeter and cured by exposure to ultraviolet radiation emitted from amedium pressure mercury arc lamp operating at 100 W/cm power for 10seconds.

Example 1

Mix 6.0 g of Irgacure 184 with 20 g IRR280 (PEG400 diacrylate) from UCB(Solution A). To 0.07 g of Irgacure 184 add 23.5 g of NNDMA and stir forone hour (keep container covered from light). Add 30 g of glycerol tothis and stir for 5 minutes, followed by 40 g of NaAMPS (58%). Stir foranother 5 minutes. Add 0.13 g of Solution A and stir the wholeformulation for 1 hour before use.

Example 2

Mix 6.0 g of Irgacure 184 with 20 g IRR280 (PEG400 diacrylate) from UCB(Solution A). To 0.07 g of Irgacure 184 add 23.5 g of NNDMA and stir forone hour (keep container covered from light). Add to this 10 g ofMowilith DM137 (50% dispersion of ethylene vinyl acetate copolymer inwater from Harco) and stir for 5 minutes. Add 30 g of glycerol to thisand stir for 5 minutes, followed by 40 g of NaAMPS (58%). Stir foranother 5 minutes. Add 0.13 g of Solution A and stir the wholeformulation for 1 hour before use.

Example 3

Mix 6.0 g of Irgacure 184 with 20 g IRR280 (PEG400 diacrylate) from UCB(Solution A). To 0.07 g of Irgacure 184 and 23.5 g of NNDMA and stir forone hour (keep container covered from light). Add to this 10 g ofMowilith DM137 (50% dispersion of ethylene vinyl acetate copolymer inwater form Harco) and stir for 5 minutes. Add 30 g of glycerol to thisand stir for 5 minutes, followed by 40 g of NaAMPS (58%). Stir foranother 5 minutes. Add 0.5 g of Pluronic L64 (poly(ethyleneglycol)—block—poly(propylene glycol)—block—poly(ethylene glycol)available from BASF). Add 0.13 g of Solution A and stir the wholeformulation for 1 hour before use.

Example 4

Mix 6.0 g of Irgacure 184 with 20 g IRR280 (PEG400 diacrylate) from UCB(Solution A). To 0.07 g of Irgacure 184 add 23.4 g of NNDMA and stir forone hour (keep container covered from light). Add to this 2 g ofMowilith DM137 (50% dispersion of ethylene vinyl acetate copolymer inwater from Harco) and stir for 5 minutes. Add 36 g of glycerol to thisand stir for 5 minutes, followed by 40.36 g of NaAMPS (58%). Stir foranother five minutes. Add 0.25 g of Pluronic L64 (poly(ethyleneglycol)—block—poly(propylene glycol)—block—poly(ethylene glycol)available from BASF). To this add 0.8 g of a 30% aqueous solution ofpoly(styrene-alt-maleic acid) sodium salt available from Aldrich andstir for 10 minutes. Add 0.13 g of Solution A and stir the wholeformulation for 1 hour before use.

Example 5

Mix 6.0 g of Irgacure 184 with 20 g IRR280 (PEG400 diacrylate) from UCB(Solution A). To 0.07 g of Irgacure 184 add 23.4 g of NNDMA and stir forone hour (keep container covered from light). Add to this 10 g ofMowilith DM137 (50% dispersion of ethylene vinyl acetate copolymer inwater from Harco) and stir for 5 minutes. Add 36 g of glycerol to thisand stir for 5 minutes, followed by 40.36 g of NaAMPS (58%). Stir foranother 5 minutes. Add 0.25 g of Pluronic L64 (poly(ethyleneglycol)—block—poly(propylene glycol)—block—poly(ethylene glycol)available from BASF). To this add 0.8 g of a 30% aqueous solution ofpoly(styrene-alt-maleic acid) sodium salt available form Aldrich andstir for 10 minutes. Add 0.13 g of solution A and stir the wholeformulation for 1 hour before use.

Example 6

Mix 6.0 g of Irgacure 184 with 20 g IR280 (PEG400 diacrylate) from UCB(Solution A). To 0.07 g of Irgacure 184 add 23.4 g of NNDMA and stir forone hour (keep container covered from light). Add to this 10 g ofMowilith DM137 (50% dispersion of ethylene vinyl acetate copolymer inwater from Harco) and stir for 5 minutes. Add 36 g of glycerol to thisand stir for 5 minutes, followed by 40.36 g of NaAMPS (58%). Stir foranother 5 minutes. Add 0.5 g of Pluronic L64 (poly(ethyleneglycol)—block—poly(propylene glycol)—block—poly(ethylene glycol)available from ASF). To this add 0.8 g of a 30% aqueous solution ofpoly(styrene-alt-maleic acid) sodium salt available from Aldrich andstir for 10 minutes. Add 0.13 g of solution A and stir the wholeformulation for 1 hour before use.

Example 7

Mix 6.0 g of Irgacure 184 with 20 g IRR280 (PEG400 diacrylate) from UCB(Solution A). To 0.07 g of Irgacure 184 add 23.4 g of NNDMA and stir forone hour (keep container covered from light). Add to this 20 g ofMowilith DM137 (50% dispersion of ethylene vinyl acetate copolymer inwater from Harco) and stir for 5 minutes. Add 36 g of glycerol to thisand stir for 5 minutes, followed by 40.36 g of NaAMPS (50%). Stir foranother 5 minutes. Add 0.5 of Pluronic L64 (poly(ethyleneglycol)—block—poly(propylene glycol)—block—poly(ethylene glycol)available from BASF). To this add 0.8 g of a 30% aqueous solution ofpoly(styrene-alt-maleic acid) sodium salt available from Aldrich andstir for 10 minutes. Add 0.13 g of solution A and stir the wholeformulation for 1 our before use.

Example 8

To parts glycerol, were added 40.4 parts of a 58% solution of the sodiumsalt of 2-acrylamido-2-methylpropane sulphonic acid (NAAMPS) (LZ2405A)together with 0.5 parts Pluronic LF64 (BASF), and the solution stirredto ensure uniform mixing. To the solution was added 0.13 parts ofsolution containing 20 parts of polyethylene glycol diacrylate (PEG600)(product of UCB Chemicals marketed under the trade name designation ofEbacryl 11) in which 6 parts of 1-hydroxycyclohexyl phenyl ketone(product of Ciba and marketed under the trade name designation ofIrgacure 184) had been dissolved. A promised solution of 8 parts butylacrylate and 15.7 parts N,N-dimethylacrylamide (Kohjin) was added tothat reaction mixture and this final solution cured by exposure to UVlight as in example 1. Optical phase contrast microscopy showed thatresultant gel to have a regularly phase-segregated surface and enhancedadhesion to skin that had previously treated with skin cream (Nivea).

Results

Subject 1 Subject 2 Greasy Greasy Dry (P_(GI)) Dry (P_(GI)) Example(P_(DI)) 1 min 10 min (P_(DI)) 1 min 10 min 1 1.75 0.13 — 1.57 0.19 — 22.96 0.16 — 3.18 0.44 — 3 2.81 0.52 0.33 2.46 0.67 0.61 4 0.81 0.15 0.260.96 0.29 0.47 5 1.2 0.52 0.69 2.2 0.83 0.88 6 1.6 0.45 0.6 2.2 0.640.56 7 1.2 0.49 0.62 1.6 0.74 0.88

What we claim is:
 1. A disposable human waste management devicecomprising: a bag; said bag further comprising an aperture and a flangesurrounding said aperture; wherein said flange further comprises awearer facing surface and a garment facing surface opposed thereto;wherein an adhesive covers at least a portion of said wearer facingsurface; wherein said adhesive has a dry peel strength (P_(DI)) and agreasy peel strength (P_(GI)); and, wherein the ratio of P_(DI) toP_(GI) ranges from 1:1 to 1:0.2.
 2. The disposable human wastemanagement device of claim 1, wherein said ratio of said dry peelstrength (P_(DI)) to said greasy peel strength (P_(GI)) ranges from 1:1to 1:0.3.
 3. The disposable human waste management device of claim 1,wherein said dry peel strength, P_(DI), ranges from 0.1N/cm to 5.0N/cm.4. The disposable human waste management device of claim 3, wherein saiddry peel strength, P_(DI), ranges from 0.5N/cm to 3.0N/cm.
 5. Thedisposable human waste management device of claim 1, wherein said greasypeel strength, P_(GI), ranges from 0.1N/cm to 5.0N/cm.
 6. The disposablehuman waste management device of claim 1, wherein said adhesive isprovided in a layer having a thickness C; wherein said adhesive has aviscous modulus at a temperature of 25° C. (G″₂₅(100 rad/sec)); and,wherein said viscous modulus, G″₂₅ (100 rad/sec), is defined by theequation: G″ ₂₅≦[(7.00+C)×3000]Pa.
 7. The disposable human wastemanagement device of claim 6 wherein said viscous modulus, G″₂₅ (100rad/sec), is defined by the equation: G″ ₂₅≦[(5.50+C)×1700]Pa.
 8. Thedisposable human waste management device of claim 6, wherein saidadhesive has an elastic modulus at a temperature of 37° C. (G′₃₇(1rad/sec)), and a viscous modulus at a temperature of 37° C. (G″₃₇, (1rad/sec)); wherein G′₃₇(1 rad/sec) ranges from 500 Pa to 20000 Pa;wherein G″₃₇(1 rad/sec) ranges from 100 Pa to 15000 Pa; and, wherein theratio G′₃₇(1 rad/sec)/G″₃₇(1 rad/sec) ranges from 1 to
 30. 9. Thedisposable human waste management device of claim 8 wherein: G′₃₇(1rad/sec) ranges from 700 Pa to 15000 Pa; and, wherein G″₃₇(1 rad/sec)ranges from 100 Pa to 10000 Pa.
 10. The disposable human wastemanagement device of claim 9, wherein: G′₃₇(1 rad/sec) ranges from 1000Pa to 10000 Pa; and, wherein G″₃₇(1 rad/sec) ranges from 300 Pa to 5000Pa.
 11. The disposable human waste management device of claim 1, whereinsaid adhesive comprises: a polymer selected from the group consisting ofacrylics, sulphonated polymers, vinyl alcohols, vinyl pyrrolidine,polyethylene oxide, and mixtures thereof; and, a plasticizer selectedfrom the group consisting of polyhydric alcohols, polyethylene glycols,sorbitol, water, and mixtures thereof.
 12. The disposable human wastemanagement device of claim 11, wherein said adhesive further comprisesat least one lipid micelling polymer.
 13. The disposable human wastemanagement device of claim 12 wherein said lipid micelling polymer is analternating polymer of styrene and maleic anhydride.
 14. The disposablehuman waste management device of claim 11 wherein said adhesive furthercomprises a surfactant.
 15. The disposable human waste management deviceof claim 14, wherein said surfactant comprises at least one propyleneoxide ethylene oxide block copolymer.
 16. The disposable human wastemanagement device of claim 11, wherein said adhesive is ahydrophilic-hydrophobic mixed phase adhesive.
 17. The disposable humanwaste management device of claim 16, wherein the ratio of saidhydrophilic components to said hydrophobic components is from 3:1 to1:3.
 18. The disposable human waste management device of claim 16,wherein said adhesive comprises a hydrophilic component selected fromthe group consisting of 2-acrylamide methyl-propane sulphonic acid,acrylic (3-sulphopropyl) ester acid and salts thereof, and combinationsthereof; and, wherein said hydrophobic component is selected from thegroup consisting of acrylamide, acrylonitrite, methylacrylate, ethylacrylate, butylacrylate, vinyl ethers, vinylpyrrolidine,gylcidyl-acrylate, methylacrylate, hydroxyethylacrylate,hyddroxypropoylacrylate, and combinations thereof.
 19. The disposablehuman waste management device of claim 1, wherein said disposable humanwaste management device may be used in conjunction with a diaper.